The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
A first-in-human Phase 1, open label study to evaluate safety and tolerability of a single ascending dose (SAD) and multiple ascending dose (MAD) of CPTX2309 intravenously administered to healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Nucleus Network Brisbane
Herston, Queensland, Australia
COMPLETEDVeritus Research
Bayswater, Victoria, Australia
RECRUITINGLinear Clinical Research
Nedlands, Western Australia, Australia
RECRUITINGNumber of participants with changes in the safety parameters
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Time frame: Up to approximately 1 Year
Number of participants with clinical laboratory assessment abnormalities
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Time frame: Up to approximately 1 Year
Number of participants with changes in the vital signs
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Time frame: Up to approximately 1 Year
Number of participants with changes in the ECG
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Time frame: Up to approximately 1 Year
Number of participants who develop anti-drug antibodies (ADAs) and Circulating Immune Complex (CIC) formation
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Time frame: Up to approximately 1 Year
Part A and B: Number of participants with change from baseline in vaccine antibody titers
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.
Time frame: Up to approximately 1 Year
Changes in serum cytokine and chemokine levels that are known to be associated with CAR-T cell therapy related toxicity
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To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Time frame: Up to approximately 1 Year
Change from baseline in soluble immunoglobulins (Ig)
To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE.
Time frame: Up to approximately 1 Year
Part C and D: Change from baseline in vaccination-induced antibody titers
To evaluate the safety and tolerability of CPTX2309 administered to participants with moderate to severe RA and SLE.
Time frame: Up to approximately 1 Year
Pharmacokinetic Parameters
Levels of CAR+ T cells, levels of CPTX2309 components
Time frame: Up to approximately 1 Year
Pharmacodynamic Parameters
Levels of circulating B cells expressed as the number of CD19 positive B cells in one microliter of blood by flow cytometry
Time frame: Up to approximately 1 Year
Part A and B: Pharmacodynamic Parameters
Percentages of naïve and memory B cells in blood by flow cytometry
Time frame: Up to approximately 1 Year
Part A and B: Pharmacodynamic Parameters
Levels of cytokines and chemokines in nanograms per milliliter of serum by ELISA
Time frame: Up to approximately 1 Year
Part C and D: Number of Participants who develop ADAs
To evaluate the PK profile of CPTX2309 in participants with moderate to severe RA or SLE.
Time frame: Up to approximately 1 Year